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U.S. Department of Health and Human Services

Class 2 Device Recall Keystone PrimaConnex Tapered Implant TC

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 Class 2 Recall
Keystone PrimaConnex Tapered Implant TC
see related information
Date Posted March 20, 2013
Recall Status1 Terminated on September 26, 2013
Recall Number Z-0973-2013
Recall Event ID 64633
Premarket Notification
510(K) Number
K051614 
Product Classification Accessories, Implant, Dental, Endosseous - Product Code NDP
Product PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Code Information Lot Number: 12857
Recalling Firm/
Manufacturer
Keystone Dental Inc
144 Middlesex Tpke
Burlington, Massachusetts 01803-4403
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Jamie Picariello
781-328-3390
Manufacturer Reason
for Recall
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Keystone Dental initially called customers on 3/11/13 and forms were completed to document these calls. In addition, a letter sent via Federal Express/or hand delivered to all distributors and customers. Product requested to be returned.
Quantity in Commerce 120 units
Distribution Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NDP and Original Applicant = LIFECORE BIOMEDICAL, INC.
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